MHRA joins forces with regulators in Australia, Canada, Singapore and Switzerland

By Jamie Bell

17 Oct 20

The MHRA is joining the ACSS Consortium, and will begin working with regulators from Australia, Canada, Singapore and…

RegulationRegulatory Policy

FDA establishes new centre to support digital health devices

By NS Medical Staff Writer

25 Sep 20

The new centre will advance the mobile health devices, Software as a Medical Device (SaMD), wearables medical devices,…

DevicesRegulationRegulatory Policy

‘Essential’ or ‘atrocious’? Medicines and Medical Devices Bill moves closer to becoming UK law

By Jamie Bell

11 Sep 20

The Medicines and Medical Devices Bill was previously passed by the UK House of Commons, and is currently…

RegulationRegulatory Policy

Regulatory and Quality Solutions acquires Maetrics to form largest medical device-focused global regulatory and quality consultancy

By NS Medical Staff Writer

10 Sep 20

Together, the two organisations form the largest agile and highly scalable consulting firm dedicated to their combined focus…

RegulationRegulatory Policy

UK medical suppliers urged to stockpile equipment and re-route supply chains as Brexit approaches

By Jamie Bell

05 Aug 20

In a letter, DHSC chief commercial officer Steve Oldfield said the medical supplies industry 'must plan for all…

RegulationRegulatory Policy

FDA reiterates warning over toxic substances in hand sanitiser products

By Jamie Bell

29 Jul 20

The FDA has issued a do-not-use list of 'dangerous' hand sanitiser products thought to be contaminated with toxic…

RegulationRecalls

FDA announces plan to resume on-site inspections in the US this month

By Jamie Bell

16 Jul 20

The FDA is monitoring Covid-19 cases and hospitalisations across the US to determine places which will be safe…

RegulationApprovals

Medtech industry ‘remains concerned’ about implementation of new EU IVD regulations

By Jamie Bell

14 Jul 20

Trade association MedTech Europe is 'raising the alarm' over the implementation of new EU IVD regulations, which are…

RegulationRegulatory Policy

MHRA warns manufacturers temperature screening is ‘not a reliable way’ to detect Covid-19

By Jamie Bell

08 Jul 20

Claiming temperature screening products can reliably detect Covid-19 could put people’s health at risk, according to the MHRA's…

RegulationRegulatory Policy

Sommetrics requests emergency use authorization to introduce its aerSleep product for sleep apnea patients at risk of COVID-19

By NS Medical Staff Writer

24 Jun 20

The intent is to reduce transmission of SARS-CoV-2 by those with documented or suspected infection by replacing CPAP…

RegulationRegulatory PolicyPatient Care Devices